Prevention & Promotion in the Treatment of Obesity

NCT02990494 | Completed

• 1 other identifier: 1R03DK106405-01A1
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

Making healthy food choices requires sacrificing immediate pleasures of consuming high calorie foods in order to achieve long-term health goals. Two strategies to encourage such future thinking are 1) focusing on the long-term consequences of consuming unhealthy foods, and 2) focusing on the long-term benefits of avoiding these unhealthy foods. Two novel behavioral weight loss (BWL) interventions will be developed based on these strategies (PREVENT and PROMOTE) and compared to standard Internet-delivered BWL to test their feasibility and efficacy in changing food choice decision-making, reducing food cravings, and ultimate weight loss.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in food choice decision-making task

  baseline baseline and within 30 days of intervention conclusion

Secondary Outcomes (3)

• adherence and acceptability questionnaire

  during 12-week intervention and within 30 days of intervention conclusion

• change in cravings and consumption questionnaire

  from baseline to within 30 days of intervention conclusion

• change in scale-measured body weight

  from baseline to within 30 days of intervention conclusion

Study Arms (3)

STANDARD

ACTIVE COMPARATOR

12-week Internet-delivered behavioral weight loss program

Behavioral: STANDARD

PREVENT

EXPERIMENTAL

an enhanced 12-week Internet-delivered behavioral weight loss program focused on preventing future negative consequences

Behavioral: PREVENT

PROMOTE

EXPERIMENTAL

an enhanced 12-week Internet-delivered behavioral weight loss program focused on promoting future benefits

Behavioral: PROMOTE

Interventions

STANDARD BEHAVIORAL

Standard Internet-delivered behavioral weight loss

Also known as: Standard Internet-delivered behavioral weight loss

STANDARD

PREVENT BEHAVIORAL

enhanced standard Internet-delivered behavioral weight loss program

Also known as: PREVENT Internet-delivered behavioral weight loss

PREVENT

PROMOTE BEHAVIORAL

enhanced standard Internet-delivered behavioral weight loss program

Also known as: PROMOTE Internet-delivered behavioral weight loss

PROMOTE

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ages 25-60
• currently overweight or obese (BMI 25-45 kg/m2)

You may not qualify if:

• lack of access to a computer and the Internet (needed once per week),
• weight loss medications
• neurological or psychiatric conditions including but not limited to schizophrenia, and bipolar disorder
• inability to attend assessments
• lack of interest in participating in a behavioral weight loss trial
• serious current physical disease for which physician supervision of diet and exercise prescription is needed
• physical problems that limit the ability to exercise
• participation in a weight loss program within the last 2 months
• intention to become pregnant in the next 3 months

Sponsors & Collaborators

• The Miriam Hospital: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Research)

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08